BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK TAMPONS

    MDR report key: 1894742 · Received November 5, 2010

    Report

    Report Number
    9611594-2010-00082
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    Manufacturer
    AVENT SA DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    K091749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IN REVIEW. CONSUMER DID NOT RETURN PRODUCT FOR EVALUATION.

    Description of Event or Problem · 1

    CONSUMER ATTEMPTED TO REMOVE A TAMPON AND THE TAMPON CAME APART INSIDE HER. CONSUMER STATED THIS MALFUNCTION OCCURRED WITH 3 DIFFERENT TAMPONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U BY KOTEX CLICK TAMPONS HEB - UNSCENTED MENSTRUAL TAMPON HEB AVENT SA DE R.L. DE C.V. REGULAR AA010401A0748

    Patients

    Seq Age Sex Outcome Treatment
    1